Status:
COMPLETED
Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Docetaxel (AC-Doc) Versus Dose-Dense Doxorubicin and Docetaxel (ADoc) in Breast Cancer
Lead Sponsor:
GBG Forschungs GmbH
Collaborating Sponsors:
German Adjuvant Breast Cancer Group
Conditions:
Primary Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this trial is to compare the rate of pathologically complete remissions achieved using a preoperative dose-intensified 8 week therapy consisting of adriamycin and docetaxel wi...
Eligibility Criteria
Inclusion
- Pre-study screening performed according to section 7.1
- Unilateral primary carcinoma of the breast, confirmed histologically by core or tru-cut biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is only allowed if less than 20% of the tumor is excised.
- Two-dimensionally measurable (mammography, ultrasound, or MRI) breast tumor
- Primary tumor \>= 2 cm in largest diameter by either palpation, sonography or mammography, or breast MRI. In patients with multifocal or multicentric breast cancer, the largest lesion should be measured.
- No evidence of distant metastases
- Life expectancy of at least 10 years, disregarding the diagnosis of cancer.
- Karnofsky index \>= 70%.
- Age 18 years or older.
- Adequate hematological, renal, and hepatic function (WBC \> 4000, platelets \> 100 000, bilirubin, serum creatinine and transaminases within 1.5 × upper normal range).
- Evidence of normal cardiac function (with or without medication) from the patient history and from electrocardiography. Normal function is confirmed by echocardiography or multiple gated acquisition (MUGA) scan.
- Negative pregnancy test and appropriate nonhormonal contraception in fertile women. Intrauterine pessaries with progestogens are allowed.
- Written informed consent and assumed compliance for therapy and follow up of the patients.
- Consent of patient, pathologist and investigator to supply tumor material of biopsy and surgery for central pathologic evaluation and examination of predictive factors.
Exclusion
- Locally advanced (stage T4), bilateral, metastatic, or inflammatory breast cancer. If one of these conditions is suspected, it has to be excluded before enrollment into study.
- Previous treatment for breast cancer, including surgery, radiation, cytotoxic, or endocrine treatments.
- Previous malignancy other than breast cancer or noninvasive breast cancer if the disease-free interval is less than 10 years.
- Previous cytotoxic treatment for any condition.
- Preexisting neurotoxicity greater than grade II.
- Active infection or other significant illness that could influence the tolerability of treatment.
- Current treatment with sex hormones (treatment has to be discontinued before the start of systemic therapy).
- Psychiatric illness or drug addiction that would preclude obtaining informed consent.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2001
Estimated Enrollment :
913 Patients enrolled
Trial Details
Trial ID
NCT00793377
End Date
September 1 2001
Last Update
November 19 2008
Active Locations (1)
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1
German Breast Group
Neu-Isenburg, Hesse, Germany, 06102